Type 2 DiabetesBdiet-6MdietNCT02709915
Effect of Meal Frequency and Timing on Insulin Dose and Clock Gene in Type 2 Diabetic Patients
A study testing Breakfast Diet (Bdiet) and 6Meal Diet (6Mdiet in people with Type 2 Diabetes, run by Tel Aviv University at 1 site in Israel.
Trial summary
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Breakfast Diet (Bdiet) and 6Meal Diet (6Mdiet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2D patients with stable insulin treatment for at least 3 month preceding the study.
- HgA1c >7.5 %.
- Age > 30 years.
- BMI: 27-34 kg/m2.
- Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs.
- Anti-hypertensive treatment will be allowed.
- Lipid-lowering medication.
Who cannot join
- Type 1 diabetes.
- Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
- Presently dieting.
- Change in weight of > 4.5 kg within 3 month prior to study onset.
- Night or rotating shift workers.
- Those who crossed more than 2 time zones during 2-week period prior to study onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day
Read the detailed description
Obese patients with type 2 diabetes (T2D) and insulin resistance (IR), often require sequential increments of total daily insulin dose (TDID). This causes weight gain, worsens IR, leading to further increase of TDID and persistent hyperglycemia. In these patients, weight loss (WL) and reduction of IR are mandatory in order to achieve glucose control with less TDID. Impaired clock gene (CG) expression is linked to obesity and IR in T2D and it was shown in animals and T2D patients treated with oral anti-hyperglycemic drugs, that WL diet with restricted meal timing to specific hours, restored CG expression and was more effective for WL and for reduction of hyperglycemia compared to isocaloric WL diet, (commonly recommended for T2D), consisting of small meals randomly distributed along the day.
The investigators hypothesized that in patients with uncontrolled T2D treated with insulin, a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for WL and for achieving glycemic control and reduction of TDID, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6Mdiet).
This will be a randomized parallel, open label clinical study. Thirty overweight and obese insulin-treated T2D patients with HbA1c>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either Bdiet or 6Mdiet. HbA1c and CG mRNA expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. The TDID (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.
- Conditions
- Type 2 Diabetes
- Being tested
- Breakfast Diet (Bdiet), 6Meal Diet (6Mdiet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast Diet (Bdiet)Other
Also called Bdiet
The Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention
6Meal Diet (6MdietOther
Also called 6Mdiet
The 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells.
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Diet (Bdiet) | Experimental | The Bdiet will consist in 3 meals with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. Receives: Other: Breakfast Diet (Bdiet); Other: 6Meal Diet (6Mdiet |
| 6 small meals diet (6Mdiet) | Active comparator | The 6Mdiet will consist on 6 meals (breakfast, lunch and dinner and 3 snacks) with distribution of calories: breakfast 15%, lunch 25%, dinner 30% and 10% each of the three snacks. Receives: Other: Breakfast Diet (Bdiet); Other: 6Meal Diet (6Mdiet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Dose
The effects of two diets (Bdiet and 6Mdiet) will be compared on their efficacy on total insulin dose reduction measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions
Measured: Baseline, 2 week and at 12 weeks
Secondary outcomes (3)
HbA1c
The effect of the two diets (Bdiet and 6Mdiet) will be compared on the efficacy on the reduction of HbA1c measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions
Measured: Baseline, 2 weeks and at 12 weeks
Overall Glycemia
The effect of the two diets on all-day glycemia will be assessed with continuous blood monitoring system at baseline, after 2 weeks and after 12 weeks of the two diet intervention
Measured: Baseline, 2 week and at 12 weeks
Clock Gene mRNA expression
The measurement of mRNA expression of clock gene in circulating white blood cells will be assessed at baseline, after 2 weeks and after 12 weeks of the two diet intervention
Measured: Baseline, 2 week and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Julio Wainstein, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709915
- Sponsor's protocol ID
- 0233-15-WOMC
- Acronym
- Bdiet-6Mdiet
- Status last verified
- Apr 2019
- First submitted
- 7 Mar 2016
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jakubowicz D, Landau Z, Tsameret S, Wainstein J, Raz I, Ahren B, Chapnik N, Barnea M, Ganz T, Menaged M, Mor N, Bar-Dayan Y, Froy O. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care. 2019 Dec;42(12):2171-2180. doi: 10.2337/dc19-1142. Epub 2019 Sep 23.
PubMed 31548244
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02709915
- Acronym / sponsor ID
- Bdiet-6Mdiet / 0233-15-WOMC
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day
Detailed description
Obese patients with type 2 diabetes (T2D) and insulin resistance (IR), often require sequential increments of total daily insulin dose (TDID). This causes weight gain, worsens IR, leading to further increase of TDID and persistent hyperglycemia. In these patients, weight loss (WL) and reduction of IR are mandatory in order to achieve glucose control with less TDID. Impaired clock gene (CG) expression is linked to obesity and IR in T2D and it was shown in animals and T2D patients treated with oral anti-hyperglycemic drugs, that WL diet with restricted meal timing to specific hours, restored CG expression and was more effective for WL and for reduction of hyperglycemia compared to isocaloric WL diet, (commonly recommended for T2D), consisting of small meals randomly distributed along the day.
The investigators hypothesized that in patients with uncontrolled T2D treated with insulin, a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for WL and for achieving glycemic control and reduction of TDID, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6Mdiet).
This will be a randomized parallel, open label clinical study. Thirty overweight and obese insulin-treated T2D patients with HbA1c>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either Bdiet or 6Mdiet. HbA1c and CG mRNA expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. The TDID (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breakfast Diet (Bdiet) | Experimental | Other: Breakfast Diet (Bdiet), Other: 6Meal Diet (6MdietThe Bdiet will consist in 3 meals with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. |
| 6 small meals diet (6Mdiet) | Active comparator | Other: Breakfast Diet (Bdiet), Other: 6Meal Diet (6MdietThe 6Mdiet will consist on 6 meals (breakfast, lunch and dinner and 3 snacks) with distribution of calories: breakfast 15%, lunch 25%, dinner 30% and 10% each of the three snacks. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T2D patients with stable insulin treatment for at least 3 month preceding the study.
- HgA1c >7.5 %.
- Age > 30 years.
- BMI: 27-34 kg/m2.
- Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs.
Key exclusion criteria (6 listed)
- Type 1 diabetes.
- Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
- Presently dieting.
- Change in weight of > 4.5 kg within 3 month prior to study onset.
- Night or rotating shift workers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast Diet (Bdiet)Also: BdietThe Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention | Other | 6 small meals diet (6Mdiet), Breakfast Diet (Bdiet) |
| 6Meal Diet (6MdietAlso: 6MdietThe 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells. | Other | 6 small meals diet (6Mdiet), Breakfast Diet (Bdiet) |
Primary outcome
Insulin Dose
Time frame: Baseline, 2 week and at 12 weeks
The effects of two diets (Bdiet and 6Mdiet) will be compared on their efficacy on total insulin dose reduction measured at baseline, after 2 weeks and at the end (12 weeks) of both diet interventions
3 secondary outcomes
HbA1c
Time frame: Baseline, 2 weeks and at 12 weeks
Overall Glycemia
Time frame: Baseline, 2 week and at 12 weeks
Clock Gene mRNA expression
Time frame: Baseline, 2 week and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Derived from this study: PubMed 31548244Jakubowicz D, Landau Z, Tsameret S, Wainstein J, Raz I, Ahren B, Chapnik N, Barnea M, Ganz T, Menaged M, Mor N, Bar-Dayan Y, Froy O. Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. Diabetes Care. 2019 Dec;42(12):2171-2180. doi: 10.2337/dc19-1142. Epub 2019 Sep 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Wainstein, MD principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast Diet (Bdiet) and 6Meal Diet (6Mdiet in people with Type 2 Diabetes, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Dose (time frame: Baseline, 2 week and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.